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Efficacy of Enteral Iron Supplementation in Critical Illness

Primary Purpose

Anemic, Critically Ill Patients

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ferrous Sulfate

Placebo Oral Tablet

About this trial

This is an interventional treatment trial for Anemic, Critically Ill Patients focused on measuring iron, critical illness, anemia, infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age > 18 years
Anemia (Hemoglobin < 13.0 g/dL)
≤ 72 hours from hospital admission
Current tolerance of enteral medications
Expected ICU LOS > 5 days

Exclusion Criteria:

Active bleeding
Chronic inflammatory disease
End-stage renal disease
Hematologic disorders
Macrocytic anemia
Current use of erythropoietin
Pregnancy
Prohibition of RBC transfusions
Moribund state in which death is imminent
Enrollment in another clinical trial

Sites / Locations

Weill Medical College of Cornell University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Iron Group

Placebo Group

Arm Description

Ferrous sulfate 325 mg either by capsule or oral solution three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.

Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.

Outcomes

Primary Outcome Measures

Hematocrit

Serum Iron Concentration

Serum Ferritin Concentration

Erythrocyte Zinc Protoporphyrin Concentration

Secondary Outcome Measures

Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital

Number of Subjects That Incurred at Least One Infection Throughout Hospital Admission

Instance of Drug-related Constipation Throughout Hospital Admission

Average Number of Days That Subjects Were Taking Antibiotics

Hospital Mortality, as Measured by Number of Subject Deaths While Admitted to Hospital

Average Length of Stay in the Hospital

Full Information

NCT ID

NCT00450177

First Posted

March 20, 2007

Last Updated

July 8, 2019

Sponsor

Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT00450177

Brief Title

Efficacy of Enteral Iron Supplementation in Critical Illness

Official Title

A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of the Effects of Enteral Iron Supplementation on Anemia and Risk of Infection in Critical Illness

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

January 2006 (Actual)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to investigate the efficacy of enteral iron supplementation for improving anemia, decreasing the risk of blood transfusion, and decreasing mortality in patients who are hospitalized in the intensive care unit. This study will also address any relationship between enteral iron supplementation and risk of infection.

Detailed Description

Critical illness is characterized by the anemia of inflammation, which is partially caused by sequestration of iron from bone marrow sites of erythropoiesis into storage within the reticuloendothelial system as ferritin. Also the majority of critically ill patients are hypoferremia, the efficacy of iron supplementation remains unknown. Furthermore, several retrospective studies have found an association between iron overload and infection. However, the relative risk/benefit profile of enteral iron supplementation with respect to infection has not been studied. The purpose of this study is to evaluate the efficacy of enteral iron supplementation in critically ill patients. The hypothesis is that enteral iron supplementation will result in both an improved hematocrit and a decreased need for blood transfusion, without increasing the risk of infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemic, Critically Ill Patients

Keywords

iron, critical illness, anemia, infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Iron Group

Arm Type

Experimental

Arm Description

Ferrous sulfate 325 mg either by capsule or oral solution three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.

Intervention Type

Drug

Intervention Name(s)

Ferrous Sulfate

Intervention Description

Iron group

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Intervention Description

Placebo group

Primary Outcome Measure Information:

Title

Hematocrit

Time Frame

Day 7, Day 14, Day 21, Day 28

Title

Serum Iron Concentration

Time Frame

Day 7, Day 14, Day 21, Day 28

Title

Serum Ferritin Concentration

Time Frame

Day 7, Day 14, Day 21, Day 28

Title

Erythrocyte Zinc Protoporphyrin Concentration

Time Frame

Day 7, Day 14, Day 21, Day 28

Secondary Outcome Measure Information:

Title

Number of Subjects That Received at Least One RBC Transfusion During Admission to the Hospital

Time Frame